Glucocorticoids and Bone in Graves' Ophthalmopathy

February 4, 2023 updated by: Torben Harsløf

The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy

Continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. The investigators aim at investigating whether this treatment regimen also affects bone metabolism.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. This effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. There is, however, less evidence that intermittent use of glucocorticoids is harmful to bone.

Graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg.

The investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with Graves' orbitopathy.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000C
        • Odense University Hospital
    • Central Denmark Region
      • Aarhus C, Central Denmark Region, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 adult patients with Graves' Ophthalopathy

Description

Inclusion Criteria:

  • Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone

Exclusion Criteria:

  • Treatment with osteoporosis medication
  • Primary hyperparathyroidism
  • Hypoparathyroidism
  • Vitamin D < 20mmol/L
  • eGFR < 30
  • Liver disease
  • Peroral treatment with glucocorticoids within last three months prior to inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
30 patients with Graves' ophthalmopathy in which treatment with intravenous methylprednisolone is indicated
Drug: Methylprednisolone
Intravenous methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbar spine bone mineral density
Time Frame: 12 weeks
Change in lumbar spine bone mineral density from baseline to week 12
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral neck bone mineral density
Time Frame: 12 weeks
Change in femoral neck bone mineral density from baseline to week 12
12 weeks
Total hip bone mineral density
Time Frame: 12 weeks
Change in total hip bone mineral density from baseline to week 12
12 weeks
Bone turnover
Time Frame: 12 weeks
Change in bone turnover measured by the biochemical markers CTx and P1NP
12 weeks
Bone structure
Time Frame: 12 weeks
Change in bone structure measured by high-resolution peripheral quantitative computed tomography
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torben Harsløf

Collaborators

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2017

Primary Completion (ACTUAL)

July 14, 2022

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRO-BONE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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